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ANALYSIS | REGULATION | spokeswoman. The company is of the

view that collecting more data in prospective clinical studies or follow-up is a better approach, as it sees this as the only way of providing answers to the questions raised. 'We are in the process of gathering and analysing more data prior to further review of the decision.' Q-Med says it has always been responsive to all questions raised by authorities. The company is also following the

ongoing debate and reviewing publications in the area. It notes that no proven risk has been identified since Macrolane was first approved in 2008. It stresses that outside France, the product will continue to be available for all treatments, including body contouring, reconstructive aesthetic procedures, and breast augmentation. Macrolane is a commercially-important

product to Q-Med, but it has a range of other products in the aesthetic and corrective portfolio. It notes that no repercussions have been seen on uses of the product in other parts of the body or in other markets. 'On the contrary, Q-Med sees many

important areas for Macrolane where the product can increase people’s health or quality of life.' Q-Med will continue to develop the product for use in a range of therapeutic areas. In the meantime, Afssaps has issued an

FAQ for users, advising them that the slowly-resorbing Macrolane is eventually eliminated by the body within 18–24 months, but this depends on the age and daily routine of the person injected, and the volume of gel that has been implanted. Recipients need not wait for total resorption before undergoing breast screening, but they should inform the radiologist of the filler's presence and when it was applied. To date, no fillers are approved in

France for use in breast reconstruction, post-breast cancer surgery, so this indication is not specifically mentioned in the Afssaps action.

Pressure on lipofilling The action deprives the market and practitioners of what is seen as a valuable alternative in breast augmentation. The range now offered includes only lipofilling and implant surgery. Paris-based plastic reconstructive and

aesthetic surgeon, Dr Yohann Derhy, believes that lipofilling with fatty tissue

14 ❚

injections in the breast is set to cause a major change in aesthetic surgery over the coming years. However, on his website he cautions

that, even with a perfect procedure, lipofilling it is seen by plastic surgery academics as not without risks. It is used in breast reconstruction, but pending further information, is not routinely used for cosmetic purposes. A national French study on lipofilling is currently under way, which will be released once the findings have been


validated. With regard to fatty

tissues, the French Society of Plastic and Reconstructive Surgery cautions that scientific data are still currently insufficient with regard to the possible interactions of the fatty tissue injected into the mammary gland. Until additional data are available, the

January 2012. The PIP implants had been removed from the French market on 29 March 2010. Afssaps recalled, that as of the end of

2009, it started to observe an increase in PIP breast implant ruptures (higher than the rate observed with implants from other manufacturers) and abnormal oozing/ perspiration/transudation of the gel. On inspection, it was observed that the

The options for breast

patients have been reduced in France, and the regulatory actions may well send them to other EU markets where Macrolane has not been banned.

society’s position is that it does not endorse the injection of autologous tissue fat in the breasts outside clinical research protocols, and advocates monitoring of patients in the medium and long term. So, the options for breast patients have

been reduced in France, and the regulatory actions may well send them to other EU markets where Macrolane has not been banned, or where other injectable procedures are practised. The market in France has thus been left open to implant providers.

New chapter in PIP scandal This market segment is not without its complications. In December 2011, Afssaps issued updated recommendations about the controversial silicone gel PIP implants manufactured by south-of-France-based Poly Implant Prothèses. It had issued a notice in April, but revised this in the light of the death of a French PIP implantee reported to it on 25 November 2011. The woman presented a breast

anaplastic large cell lymphoma, which the agency said was an epidemiological factor to be considered in the 30 000 carriers of PIP implants (out of a national breast implant total of 500 000). The UK Medicines and Healthcare products Regulatory Agency (MHRA) takes the view that there is no risk of cancer from leakage of the industrial grade filler used by PIP. A UK review was launched in

January/February 2012 |

silicone gel filler was not the medical quality of silicone gel required for breast implants; the mechanical strength was not in compliance; and there was an 'irritant' behaviour of the gel, which was not seen in other brands. The regulatory agency’s

head of medical devices, Jean-Claude Ghislain, said that the implants did not

meet CE-marking standards. Afssaps recommends that implantees seek a check-up annually, and considers that some 1000 women will need to replace their implants soon. French health minister, Xavier Bertrand, advised women with PIP implants to have them removed as a preventive measure, but said that such action was not urgent. One initial concern was who would pay

for the revision surgery. In breast reconstruction cases, post-cancer, the sickness insurance fund assumes the cost. For cosmetic surgery, it is usually a grey area, but in its recent notice Afssaps declared that all women with PIP breast implants will be reimbursed for their medical and surgical expenses related to explantation (ultrasound, analysis, implant

removal, postoperative

examination); and women who have had breast reconstruction after cancer surgery will also be reimbursed for the implantation of a new prosthesis. It was a complex and controversial year

in the French breast cosmetic procedures/ breast surgery market, to say the least.


1. Chaput B, Chavoin JP, Crouzet C, Grolleau JL, Garrido I. Macrolane is no longer allowed in aesthetic breast augmentation in France. Will this decision extend to the rest of the world? J Plast Reconstr Aesthet Surg 2001 [Epub ahead of print]

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